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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K190285
Device Name L300 Go System
Applicant
Bioness Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Applicant Contact Mercedes Bayani
Correspondent
Bioness Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Correspondent Contact Shanna Hu
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received02/11/2019
Decision Date 03/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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